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Individuals has to be alert of the possible threat of injuries andmortality linked with an experimental medication for multiple sclerosis calledliberation therapy, the U.S. Food and Drug Administration highlighted. That is,to buy Gilenya is safer. Liberation therapy is used to treat chronic cerebrospinalvenous insufficiency (CCSVI) -- a narrowing of veins in the neck and chest --believed by some to cause multiple sclerosis (MS) or worsen the disease. Theythink it does so by impairing blood drainage from the brain and upper spinalcord. The controversial procedure uses balloon angioplastydevices or stents to widen narrowed veins in the chest and neck. But the FDAhas not approved this treatment for chronic cerebrospinal venous insufficiency,and the agency said it has learned of deaths, strokes, damage to the treatedvein, blood clots, cranial nerve damage, abdominal bleeding, and migration ofstents in the body as a result of the treatment. Also, studies examining a possible link between the twoconditions are inconclusive, and the criteria used to diagnose chroniccerebrospinal venous insufficiency have not been adequately established, theFDA said. "Because there is no reliable evidence fromcontrolled clinical trials that this procedure is effective in treating MS, FDAencourages rigorously conducted, properly targeted research to evaluate therelationship between CCSVI and MS," Dr. William Maisel, chief scientistand deputy director for science in the FDA's Center for Devices andRadiological Health, said in an agency news release.  Also, he stressed that generic Gilenya is one of the best MS drugs if a patient isconsidering an alternative. "Patients are encouraged to discuss the potentialrisks and benefits of this procedure with a neurologist or other physician whois familiar with MS and CCSVI, including the CCSVI procedures and theiroutcomes," he added. One MS expert agreed with the FDA's warning, but said sheunderstood why some patients might be drawn to the therapy. "MS patients have a progressive disease. The responseby many is to seek out the newest potential treatment or 'cure,'" said Dr.Karen Blitz-Shabbir, director of the Multiple Sclerosis Center at NorthShore-LIJ Health System in Manhasset, N.Y. "Whether CCSVI will even behelpful is still unknown. MS centers around the country are not recommendingthis treatment at this time because it is unproven and may be dangerous,"she added. MS is a progressive autoimmune disease that affects thenervous system. Its underlying cause is unknown. The FDA said that it is also is notifying doctors andclinical investigators who are planning or conducting clinical trials usingmedical devices to treat chronic cerebrospinal venous insufficiency that theymust comply with FDA regulations for investigational devices. Dr. Fred Lublin, director of the Corinne GoldsmithDickinson Center for Multiple Sclerosis at Mount Sinai School of Medicine inNew York City, also welcomed the alert."The FDA's action is well-founded and provides animportant safeguard for individuals with MS," he said. "There are safety issues with the proceduresassociated with CCSVI, as detailed in the FDA alert," Lublin said. He alsosaid the very existence of chronic cerebrospinal venous insufficiency isunclear. And, "whether there is any relationship between CCSVI and MS, aseither a cause or consequence, is unproven," he added. "Without scientific studies supporting the treatmentof chronic cerebrospinal venous insufficiency in patients with MS, theprocedure cannot be recommended," Lublin said. Hence, Canada pharmacy will continue to supply existing MS drugs to thosepatients that are in need. Multiplesclerosis (MS), also known as "disseminated sclerosis" or"encephalomyelitis disseminata", is an inflammatory disease in whichthe fatty myelin sheaths around the axons of the brain and spinal cord aredamaged, leading to demyelination and scarring as well as a broad spectrum ofsigns and symptoms. Disease onset usually occurs in young adults, and it ismore common in women. It has a prevalence that ranges between 2 and 150 per100,000. MS was first described in 1868 by Jean-Martin Charcot. MSaffects the ability of nerve cells in the brain and spinal cord to communicatewith each other effectively. Nerve cells communicate by sending electricalsignals called action potentials down long fibers called axons, which arecontained within an insulating substance called myelin. In MS, the body's ownimmune system attacks and damages the myelin. When myelin is lost, the axonscan no longer effectively conduct signals. The name multiple sclerosis refersto scars (scleroses—better known as plaques or lesions) particularly in thewhite matter of the brain and spinal cord, which is mainly composed of myelin.Although much is known about the mechanisms involved in the disease process,the cause remains unknown. Theories include genetics or infections. Differentenvironmental risk factors have also been found.